ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-555
Product ID 72189-555_4c4aad0a-641f-1aa7-e063-6294a90a13da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216759
Listing Expiration 2027-12-31
Marketing Start 2024-06-03

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitor [epc] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189555
Hyphenated Format 72189-555

Supplemental Identifiers

RxCUI
834022
UNII
4EVE5946BQ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ketorolac tromethamine (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number ANDA216759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30)
source: ndc

Packages (4)

72189-555-10 10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10) 72189-555-15 15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15) 72189-555-20 20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20) 72189-555-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30)

Ingredients (1)

ketorolac tromethamine (10 mg/1)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c4aad0a-641f-1aa7-e063-6294a90a13da", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["19fffe42-a02d-26eb-e063-6294a90aea5a"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10)", "package_ndc": "72189-555-10", "marketing_start_date": "20240603"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15)", "package_ndc": "72189-555-15", "marketing_start_date": "20240603"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20)", "package_ndc": "72189-555-20", "marketing_start_date": "20240603"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30)", "package_ndc": "72189-555-30", "marketing_start_date": "20240603"}], "brand_name": "Ketorolac Tromethamine", "product_id": "72189-555_4c4aad0a-641f-1aa7-e063-6294a90a13da", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72189-555", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA216759", "marketing_category": "ANDA", "marketing_start_date": "20240603", "listing_expiration_date": "20271231"}